It’s called “Second Breath,” and this piece of equipment will save lives.

“Without this ventilator there are a lot of folks who might not have a chance at a breath,” said Dr. Mada Helou, from University Hospitals.

Three Cleveland organizations put their innovative skills, knowledge and can-do attitude together to create and manufacturer a breathing pump that will alleviate some of the demand for ventilators, all across the country.

“We like to respond to things, and more importantly the team likes to respond. There were eight engineers that developed this and these guys wanted to do something and they came to me,” said Dan T. Moore, president and CEO, Dan T. Moore Co.

It collaborated with several other organizations and in three weeks, designed “Second Breath.”

“Coronavirus’ main target is the lungs. It effects many organs, but it has a profound effect on our ability to hold oxygen within our blood,” said Dr. Helou.

Experts said an average ventilator costs anywhere from $20,000 and up to $100,000. Second Breath costs about $6,000.

Dan T. Moore Co. has made about 36 ventilators and they’re ready to ship out around the world. Engineers told 19 News they can design about a hundred ventilators a day.

The team tells 19 News they are proud.

“I think great innovation comes under pressure and when the COVID-19 surge showed up folks thought you know what, we need to respond to this quickly,” said Dr. Helou. “Everything about this says Cleveland. It speaks helping people and it speaks collaboration,” she said. “Cleveland, you’ve done this!”

Hospitals in New York City are gearing up to use the blood of people who have recovered from COVID-19 as a possible antidote for the disease. Researchers hope that the century-old approach of infusing patients with the antibody-laden blood of those who have survived an infection will help the metropolis — now the US epicentre of the outbreak — to avoid the fate of Italy, where intensive-care units (ICUs) are so crowded that doctors have turned away patients who need ventilators to breathe.

The efforts follow studies in China that attempted the measure with plasma — the fraction of blood that contains antibodies, but not red blood cells — from people who had recovered from COVID-19. But these studies have reported only preliminary results so far. The convalescent-plasma approach has also seen modest success during past severe acute respiratory syndrome (SARS) and Ebola outbreaks — but US researchers are hoping to increase the value of the treatment by selecting donor blood that is packed with antibodies and giving it to the patients who are most likely to benefit.

A key advantage to convalescent plasma is that it’s available immediately, whereas drugs and vaccines take months or years to develop. Infusing blood in this way seems to be relatively safe, provided that it is screened for viruses and other infectious agents. Scientists who have led the charge to use plasma want to deploy it now as a stopgap measure, to keep serious infections at bay and hospitals afloat as a tsunami of cases comes crashing their way.

“Every patient that we can keep out of the ICU is a huge logistical victory because there are traffic jams in hospitals,” says Michael Joyner, an anaesthesiologist and physiologist at the Mayo Clinic in Rochester, Minnesota. “We need to get this on board as soon as possible, and pray that a surge doesn’t overwhelm places like New York and the west coast.”

On 23 March, New York governor Andrew Cuomo announced the plan to use convalescent plasma to aid the response in the state, which has more than 25,000 infections, with 210 deaths. “We think it shows promise,” he said. Thanks to the researchers’ efforts, the US Food and Drug Administration (FDA) today announced that it will permit the emergency use of plasma for patients in need. As early as next week, at least two hospitals in New York City — Mount Sinai and Albert Einstein College of Medicine — hope to start using coronavirus-survivor plasma to treat people with the disease, Joyner says.

After this first rollout, researchers hope the use will be extended to people at a high risk of developing COVID-19, such as nurses and physicians. For them, it could prevent illness so that they can remain in the hospital workforce, which can’t afford depletion.

And academic hospitals across the United States are now planning to launch a placebo-controlled clinical trial to collect hard evidence on how well the treatment works. The world will be watching because, unlike drugs, blood from survivors is relatively cheap and available to any country hit hard by an outbreak.

Scientists assemble

Arturo Casadevall, an immunologist at Johns Hopkins University in Baltimore, Maryland, has been fighting to use blood as a COVID-19 treatment since late January, as the disease spread to other countries and no surefire therapy was in sight. Scientists refer to this measure as ‘passive antibody therapy’ because a person receives external antibodies, rather than generating an immune response themselves, as they would following a vaccination.

The approach dates back to the 1890s. One of the largest case studies occurred during the 1918 H1N1 influenza virus pandemic. More than 1,700 patients received blood serum from survivors, but it’s difficult to draw conclusions from studies that weren’t designed to meet current standards.

During the SARS outbreak in 2002–03, an 80-person trial of convalescent serum in Hong Kong found that people treated within 2 weeks of showing symptoms had a higher chance of being discharged from hospital than did those who weren’t treated. And survivor blood has been tested in at least two outbreaks of Ebola virus in Africa with some success. Infusions seemed to help most patients in a 1995 study in the Democratic Republic of the Congo, but the study was small and not placebo controlled. A 2015 trial in Guinea was inconclusive, but it didn’t screen plasma for high levels of antibodies. Casadevall suggests that the approach might have shown a higher efficacy had researchers enrolled only participants who were at an early stage of the deadly disease, and therefore were more likely to benefit from the treatment.

Casadevall corralled support for his idea through an editorial in the Wall Street Journal, published on 27 February, which urged the use of convalescent serum because drugs and vaccines take so long to develop. “I knew if I could get this into a newspaper, people would react, whereas if I put it into a science journal, I might not get the same reaction,” he says.

He sent his article to dozens of colleagues from different disciplines, and many joined his pursuit with enthusiasm. Joyner was one. Around 100 researchers at various institutes self-organized into different lanes. Virologists set about finding tests that could assess whether a person’s blood contains coronavirus antibodies. Clinical-trial specialists thought about how to identify and enroll candidates for treatment. Statisticians created data repositories. And, to win regulatory clearance, the group shared documents required for institutional ethical-review boards and the FDA.

Tantalizing signs

Their efforts paid off. The FDA’s classification today of convalescent plasma as an ‘investigational new drug’ against coronavirus allows scientists to submit proposals to test it in clinical trials, and lets doctors use it compassionately to treat patients with serious or life-threatening COVID-19 infections, even though it is not yet approved.

“This allows us to get started,” says Joyner. Physicians can now decide whether to offer the therapy to people with very advanced disease, or to those that seem to be headed there — as he and other researchers recommend. He says hospitals will file case reports so that the FDA gets a handle on which approaches work best.

Researchers have also submitted to the FDA three protocols for placebo-controlled trials to test the plasma, which they hope will take place at hospitals affiliated with Johns Hopkins, the Mayo Clinic and Washington University in St. Louis, along with other universities that want to take part.

Future directions

The US tests of convalescent plasma aren’t the first. Since early February, researchers in China — where the coronavirus emerged late last year — have launched several studies using the plasma. Researchers have yet to report on the status and results of these studies. But Liang Yu, an infectious-disease specialist at Zhejiang University School of Medicine in China, told Nature that in one preliminary study, doctors treated 13 people who were critically ill with COVID-19 with convalescent plasma. Within several days, he says the virus no longer seemed to be circulating in the patients, indicating that antibodies had fought it off. But he says that their conditions continued to deteriorate, suggesting that the disease might have been too far along for this therapy to be effective. Most had been sick for more than two weeks.

In one of three proposed US trials, Liise-anne Pirofski, an infectious-disease specialist at Albert Einstein College of Medicine, says researchers plan to infuse patients at an early stage of the disease and see how often they advance to critical care. Another trial would enrol severe cases. The third would explore plasma’s use as a preventative measure for people in close contact with those confirmed to have COVID-19, and would evaluate how often such people fall ill after an infusion compared with others who were similarly exposed but not treated. These outcomes are measurable within a month, she says. “Efficacy data could be obtained very, very quickly.”

Even if it works well enough, convalescent serum might be replaced by modern therapies later this year. Research groups and biotechnology companies are currently identifying antibodies against the coronavirus, with plans to develop these into precise pharmaceutical formulas. “The biotech cavalry will come on board with isolating antibodies, testing them, and developing into drugs and vaccines, but that takes time,” says Joyner.

In some ways, Pirofski is reminded of the urgency she felt as a young doctor at the start of the HIV epidemic in the early 1980s. “I met with medical residents last week, and they are so frightened of this disease, and they don’t have enough protective equipment, and they are getting sick or are worried about getting sick,” she says. A tool to help to protect them now would be welcomed.

Since becoming involved with the push for blood as a treatment, Pirofski says another aspect of the therapy holds her interest: unlike a pharmaceutical product bought from companies, this treatment is created by people who have been infected. “I get several e-mails a day from people who say, ‘I survived and now I want to help other people’,” she says. “All of these people are willing to put on their boots and brush their teeth, and come help us do this.”

The roads may have fewer cars on them these days, but for many truckers, the journey feels a lot longer.

by CHRISTIAN COTRONEO

There’s no shortage of people facing extraordinary adversity to help us maintain some semblance of civilization in these pandemic times.

There are the usual suspects — doctors, nurses, firefighters — who make courage under fire seem so routine.

And then there are truckers.

Rain, shine or pandemic, the U.S. relies on about 3.5 million truck drivers to keep goods — the lifeblood of an economy — in circulation.

That includes canned foods and non-perishables like tuna and rice and beans, bound for small stores and shops in every nook of the country. And yes, there’s always a need for more toilet paper on Aisle 12.

There’s also Amazon — and the unending stream of smart speakers, cordless vacuums and pretzel crackers that Americans feel they need at a time like this.

That’s to say nothing of essential medical supplies and the equipment that’s sadly emblematic of our times: masks, ventilators, disinfectant. It’s not just about distributing those goods to stores and homes, but getting the raw materials, like plastic and pulp, to the manufacturers.

All of it is literally a trucker’s burden to bear. And that burden has never been heavier.

Taking truck drivers for granted

“I think people, quite frankly, take truck drivers for granted when things are normal,” Todd Jadin, of Wisconsin-based Schneider, which boasts 14,000 drivers under its umbrella, tells USA Today. “The work they do every day is that much more important right now.”

Sure, driving is a little easier these days — thanks to the millions of Americans who are staying home and trying to social distance the coronavirus to death.

But for truckers, already accustomed to driving as many as 11 hours per day, the road has gotten even longer. That’s because, for all the miles a trucker logs, there’s always been a bright beacon at the side of just about every highway: the iconic truck stop.

Maybe it’s a diner, where a driver can get a meal and even take a shower. Or a parking lot, where the engines finally go silent, and truckers catch some much-needed shut-eye.

The thing is, as Wired reports, those gleaming lights are going dark. Side-of-the-road eateries are closing to discourage public gatherings. State authorities are even shuttering places that specifically cater to truckers — spots at turnpikes that offer showers, parking and bathrooms.

One of American’s biggest travel center operators, TA-Petro, recently closed all of its driver lounges and fitness centers, Wired also notes.

The few facilities still open are crowded and, as you might imagine, an increasingly risky proposition in these viral times.

But that’s one area where you can help. Follow the lead of police officers in Eufaula, Alabama, who help truckers who can’t fit their rigs through the drive-thru — often the only option when restaurant dining rooms are closed.

“We will either go get something for you or give you a ride to the nearest drive-thru (if you don’t mind riding in the back seat!” the department posted on Facebook. “If manpower is such that we cannot assist, we will secure someone that can.”

“If a school system closes down, our employees may not have child care,” T.J. O’Connor of Kansas-based trucking-and-logistics company YRC Worldwide, tells USA Today. “Or we have a driver go out there to make a pickup and there’s a sign on the door that says one of the employees tested positive and they’re closed. What do you do?”

But these days, too much is riding on a trucker’s cargo for them to simply stay home.

“Times like this, people need to realize that everything you have is brought to you by truck drivers. Right now, we’re the ones out there taking chances on our health and our safety to make sure there’s food in the grocery stores,” Robert Stewart, a Pennsylvania-based trucker tells CBS News.

In other words, they deserve our admiration now more than ever.

As Deb Labree, an independent owner-operator based in Missouri, tells the industry journal Freight Waves, “When this pandemic is over, I hope truckers who were a huge part of keeping America moving and the shelves stocked realize they have achieved hero status in my book.”